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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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Applicant
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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kappa 400 MEDTRONIC Inc. P970012S093 06/11/2013
lead extension, percutaneous extension kit, leads MEDTRONIC NEUROMODULATION P970004S152 12/06/2016
interstim therapy for urinary control MEDTRONIC NEUROMODULATION P970004S151 06/17/2013
interstim therapy MEDTRONIC NEUROMODULATION P970004S141 11/01/2012
vns therapy aspiresr LivaNova USA, Inc. P970003S173 05/29/2015
sls spectranetics laser sheaths Spectranetics (Philips) P960042S036 05/24/2012
sls spectranetics laser sheaths Spectranetics (Philips) P960042S032 02/17/2012
teligen, energen, punctua, incepta, origen, inogen, dynagen, autogen icd devices BOSTON SCIENTIFIC P960040S362 02/05/2016
teligen, progeny icd and ng icd models BOSTON SCIENTIFIC P960040S316 07/16/2014
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd BOSTON SCIENTIFIC P960040S306 04/11/2014

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